Tag Archives: FDA

For every new medication or pharmaceutical device, there is a list of side effects. In the case of implantable vena cava (IVC) filters, C.R. Bard and Bard Peripheral Vascular, Inc. downplayed the risks involved in keeping the filters in bodies extending past a few months. The purpose of the IVC filters is to stop blood clots that may result in death. Despite the caution involved, filters were implanted for long-term use in the 1970s. In the early 2000’s, the FDA approved the short-term use of IVC filters. It was possible for patients to receive the filter implants, even if taking medication was an alternative remedy. Read more

Several companies have been on the receiving end of lawsuits claiming lack of protein in their supplements. A large number of the companies in this $7 billion industry are being accused of selling products with less protein content than what they advertise on the label. “Arnold Schwarzenegger Series Iron Mass, for instance, contains half the protein stated on its label, according to third party testing in one lawsuit”. FDA regulations require that content labels on all dietary supplements be accurate and not misleading to the consumers. In this case the expectation is that protein content be evaluated based on actual protein sources, not fillers such as amino acids.

Sainah Theodore is suing a Natural Health Food Center in East New York after she claimed a diet pill caused her to argue with strangers, stop her car in the middle of intersections, stab pillows and ultimately land her in a mental hospital. The weight loss pill initially caused her to sleep lightly and eventually resulted in six days of insomnia. Reports state that she sent her mother irrational and aggressive text messages and told a friend she was hearing voices. The pills are said to have been spiked with illegal stimulants that caused her to suffer from insomnia and act bizarrely. “I couldn’t believe all of this happened to me. It was a blur. I had no recollection of my behavior,” (Yaniv, 2014) said Theodore.

Labeled by the U.S. Government as the largest drug-safety settlement to date with a generic drug manufacturer; Ranbaxy Laboratories has just pled guilty to three felony counts under the Food, Drug, and Cosmetic act, and four felony counts of of providing false statements to the United States Food and Drug Administration.

The company failed to conduct proper safety and quality tests of several drugs that were manufactured in the Indian plants. These generic drugs were manufactured in Paonta Sahib, and Dewas India. The major drugs involved in this case were the generic versions of Gabapentin, Sotret, and Ciprofloxacin. This is a great cause for concern because compared to the plants in the United States which are inspected by the F.D.A. once every two years, plants over seas are inspected about once every seven to thirteen years. It has been proven between June and August of 2007, certain batches of medications had tested positive for “unknown impurities” and had unreliable shelf lives. Ranbaxy waited two months until October of that year to report these impurities.

Some government employees are finally allowed to exercise the right to voice their concerns in a consequence free environment now that President Obama signed the Whistleblower Protection Enhancement Act (WPEA). This act will help resolve the issue of the FDA and USDA intimidating their employees to keep their concerns quiet. Since employees of these government agencies feared retaliation for speaking out against their employer, many have sat idly by while they believed public health was at risk. The consequence of demotion, firing, or relocation was enough for employees to keep their opposition to themselves. However, the WPEA has now been signed and FDA and USDA employees are officially free to voice their concerns to supervisors without the possibility of unfair retaliation. This is a step in the right direction for honest and healthy working conditions in an industry that has a big impact on the food we eat.